Early Beta blocker Administration before reperfusion in patients with a myocardial infarction who are planned to undergo a percutaneous coronary intervention within 12 hours

Phase 1

• Conditions: Patients with acute ST elevation myocardial infarction, scheduled for emergency coronary angioplasty; MedDRA version: 18.0Level: LLTClassification code 10066641Term: Acute myocardial infarction, of anterior wallSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-023394-19-NL
• Lead Sponsor: Maatschap Cardiologie Isala

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-17
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 601

Inclusion Criteria

• Patients = 18 years of age with symptoms of acute ST-elevation myocardial infarction of more than 30 min but less than 12 hours and on the ECG ST-segment elevation of >= 0.1 mV in two adjacent limb electrocardiograph (ECG) leads and >= 0.2 mV in two adjacent precordial ECG leads or new left bundle branch block (LBBB).
• Verbal followed by written informed consents.
• PCI-center located within 90 minutes

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 301
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

• Severe Hypotension (systolic blood pressure < 100 mmHg)
• Cardiogenic shock (severe dyspnoea, hypotension and oxygen saturation <92%, systolic blood pressure < 100 mmHg and heartrate > 110/min)
• Known with asthma
• Severe bradycardia at sinusrythm (< 60 bpm)
• PR interval >240 ms or second- and/or third degree atrio-ventricular (AV) block
• History of previous myocardial infarction
• Killip class III-IV
• Pacemaker/implantable cardioverter defibrillator (ICD)
• Unable to provide informed consent
• Patient is pregnant or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified